Amanda is EU medtech regulatory affairs editor at Medtech Insight. She has been reporting and providing analysis on developments in the field of medical technology regulatory affairs, with particular focus on the current and future EU regulations for medical devices, IVDs and device/drug combination products since the mid-1980s. She monitors and reports on all aspects of the implementation of the EU’s Medical Device and IVD Regulations, including relevant guidances, standards, expert opinions and ongoing challenges for all players in meeting the new requirements.
Her features have appeared in a variety of in-house publications and services. She also wrote medtech regulatory country profiles for Citeline’s former EU Law service and regularly contributes to In Vivo. Amanda regularly interviews experts in the EU medtech regulatory space and publishes interview podcasts. She also has experience in providing medtech regulatory strategy consultancy services, is often invited to speak and chair at EU meetings on medtech regulations and drug/device combination regulatory issues and is a frequent advisor to conference organizations.
Amanda enjoys taking part in LinkedIn discussions, has a background in the language and literature of Italy and France, and a passion for being part of the EU scene.
Latest From Amanda Maxwell
There is a much-acknowledged urgency to ensure medtech products are certified as fast as possible, with fears persisting that delays will result in notified body bottlenecks and product shortages.
After some 10 years of the implementation of the EU’s Medical Device and IVD Regulations being an annual agenda item at December Council of the EU meetings, the scale of problems remains the same.
In the EU, notified bodies are usually designated for a wide spectrum of testing of different types of medical devices under the Medical Device Regulation. The latest organization to be named, however, is a specialist.
The EU notified body association, TEAM-NB, is working hard to support industry with its MDR and IVDR compliance efforts. Its first technical documentation training session highlighted where help is likely to be most needed.
The EU’s Medical Device Regulation regulates a small group of products with a mainly aesthetic purpose for the first time. How much notified body capacity will these potentially risky products demand?
There are now 41 notified bodies in total under the EU’s Medical Device Regulation.